Expandable intubation assemblies

ABSTRACT

Expandable intubation assemblies and methods for using and making the same are provided.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application claims the benefit of prior filed U.S. ProvisionalPatent Application No. 62/337,670, filed May 17, 2016, which is herebyincorporated by reference herein in its entirety.

TECHNICAL FIELD

This disclosure relates to expandable assemblies and, more particularly,to expandable intubation assemblies and methods for using and making thesame. d methods for using and making the same.

BACKGROUND OF THE DISCLOSURE

Various medical procedures (e.g., intubation procedures) involve adistal end of a tube being inserted into a specific area of a patientand then using the tube for injecting material into the patient and/orfor removing material from the patient. However, safely securing such atube at a particular position within the patient during use hasheretofore been infeasible. Moreover, safely preventing certain materialfrom passing along the external surface of such a tube during use hasheretofore been infeasible.

SUMMARY OF THE DISCLOSURE

This document describes expandable assemblies and methods for using andmaking the same.

For example, an intubation assembly may be include a body structureextending from a proximal body end to a distal body end, an intubationpassageway extending within the body structure and along at least anintubation portion of the length of the body structure from a proximalintubation passageway opening to a distal intubation passageway opening,an expander subassembly coupled to the body structure for defining anexpander passageway between the expander subassembly and the bodystructure, and an inflation passageway extending along at least aninflation portion of the length of the body structure from a proximalinflation passageway opening to a distal inflation passageway opening,wherein the distal inflation passageway opening fluidly couples theinflation passageway to the expander passageway, the expandersubassembly includes a proximal expander subassembly portion defining aproximal portion of the expander passageway between the proximalexpander subassembly portion and a proximal portion of the bodystructure and a distal expander subassembly portion defining a distalportion of the expander passageway between the distal expandersubassembly portion and a distal portion of the body structure, theproximal portion of the expander passageway is fluidly coupled to thedistal portion of the expander passageway, and, when a volume of fluidis retained within the combined space defined by the inflationpassageway and the expander passageway, a portion of the volume of thefluid is transferred from the proximal portion of the expanderpassageway to the distal portion of the expander passageway when anexternal force is applied to the proximal expander subassembly portionand the portion of the volume of the fluid is transferred from thedistal portion of the expander passageway to the proximal portion of theexpander passageway when the external force is removed from the proximalexpander subassembly portion.

As another example, a method of intubating a patient with an intubationassembly may be provided, where the assembly may include a bodystructure, an intubation passageway extending within the body structureand along at least an intubation portion of the length of the bodystructure from a proximal intubation passageway opening to a distalintubation passageway opening, an expander subassembly coupled to thebody structure for defining an expander passageway between the expandersubassembly and the body structure, and an inflation passagewayextending along at least an inflation portion of the length of the bodystructure from a proximal inflation passageway opening to a distalinflation passageway opening, wherein the distal inflation passagewayopening fluidly couples the inflation passageway to the expanderpassageway, wherein the expander subassembly includes a proximalexpander subassembly portion defining a proximal portion of the expanderpassageway between the proximal expander subassembly portion and aproximal portion of the body structure and a distal expander subassemblyportion defining a distal portion of the expander passageway between thedistal expander subassembly portion and a distal portion of the bodystructure, wherein the distal inflation passageway opening fluidlycouples the inflation passageway to the distal portion of the expanderpassageway, wherein the inflation passageway further includes anintermediate inflation passageway opening that fluidly couples theinflation passageway to the proximal portion of the expander passageway,and wherein the proximal portion of the expander passageway is fluidlycoupled to the distal portion of the expander passageway only via theinflation passageway, and wherein the method may include positioning theexpander subassembly within the patient and, while the expandersubassembly is positioned within the patient, providing a volume offluid within the combined space defined by the inflation passageway andthe expander passageway, wherein the providing expands each one of theproximal portion of the expander passageway and the distal portion ofthe expander passageway, retaining the volume of the fluid within thecombined space, and, while the volume of the fluid is retained withinthe combined space, passing other fluid through the intubationpassageway for treating the patient.

As yet another example, an intubation assembly may include a bodystructure extending from a proximal body end to a distal body end, anintubation passageway extending within the body structure and along atleast an intubation portion of the length of the body structure from aproximal intubation passageway opening to a distal intubation passagewayopening, an expander subassembly coupled to the body structure fordefining an expander passageway between the expander subassembly and thebody structure, an inflation passageway extending along at least aninflation portion of the length of the body structure from a proximalinflation passageway opening to a distal inflation passageway opening,and an auxiliary passageway extending along at least an auxiliaryportion of the length of the body structure from a proximal auxiliarypassageway opening to a distal auxiliary passageway opening, wherein thedistal auxiliary passageway opening is directed along the length of thebody structure at least one of towards the expander subassembly and awayfrom the expander subassembly, wherein the distal inflation passagewayopening fluidly couples the inflation passageway to the expanderpassageway, and wherein, when a volume of fluid is retained within thecombined space defined by the inflation passageway and the expanderpassageway, the expander subassembly is operative to remain in anexpanded configuration.

This Summary is provided only to summarize some example embodiments, soas to provide a basic understanding of some aspects of the subjectmatter described in this document. Accordingly, it will be appreciatedthat the features described in this Summary are only examples and shouldnot be construed to narrow the scope or spirit of the subject matterdescribed herein in any way. Unless otherwise stated, features describedin the context of one example may be combined or used with featuresdescribed in the context of one or more other examples. Other features,aspects, and advantages of the subject matter described herein willbecome apparent from the following Detailed Description, Figures, andClaims.

BRIEF DESCRIPTION OF THE DRAWINGS

The discussion below makes reference to the following drawings, in whichlike reference characters may refer to like parts throughout, and inwhich:

FIG. 1 is a cross-sectional view of a patient with an intubationassembly in an insertion state;

FIGS. 1A-1C are cross-sectional views, similar to FIG. 1, of the patientof FIG. 1 with the intubation assembly of FIG. 1 in various illustrativeexpanded states;

FIG. 1D is a cross-sectional view, similar to FIGS. 1-1C, of the patientof FIGS. 1-1C with the intubation assembly of FIGS. 1-1C in a removalstate;

FIG. 2 is a side elevational view of the intubation assembly of FIGS.1-1D in an insertion state;

FIG. 2A is a cross-sectional view of the intubation assembly of FIG. 2taken from line IIA-IIA of FIG. 2;

FIG. 2B is a cross-sectional view of the intubation assembly of FIGS. 2and 2A taken from line IIB-IIB of FIG. 2;

FIG. 3 is a cross-sectional view of the intubation assembly of FIGS.2-2B in an equilibrium geometry of an expanded state;

FIG. 4 is a side elevational view of the intubation assembly of FIGS.2-3 in the insertion state within a patient;

FIG. 5 is a side elevational view of the intubation assembly of FIGS.2-4 in the equilibrium geometry of the expanded state within a patient;

FIG. 6 is a side elevational view of the intubation assembly of FIGS.2-5 in a deformed geometry of the expanded state within a patient;

FIG. 7 is a side elevational view of the intubation assembly of FIGS.2-6 in the equilibrium geometry of the expanded state within a patient;

FIG. 8 is a side elevational view of another intubation assembly in aninsertion state;

FIG. 9 is a cross-sectional view of the intubation assembly of FIG. 8 inan equilibrium geometry of an expanded state;

FIGS. 10 and 11 are different perspective views of a portion of theintubation assembly of FIGS. 2-7;

FIG. 12 is a cross-sectional view of the portion of the intubationassembly of FIGS. 10 and 11;

FIGS. 13 and 14 are different perspective views of an alternativeportion of the intubation assembly of FIGS. 2-7;

FIG. 15 is a cross-sectional view of the portion of the intubationassembly of FIGS. 13 and 14; and

FIG. 16 is a flowchart of an illustrative process for intubating apatient.

DETAILED DESCRIPTION OF THE DISCLOSURE

FIGS. 1-1D show an illustrative assembly 100 in various configurationsor stages of use with respect to a patient 1. Assembly 100 may be anintubation assembly or any other suitable assembly for use in anysuitable procedure with respect to any suitable patient 1. As shown inFIGS. 1-1D, for example, assembly 100 may extend between a proximal orfirst assembly end 101, which may have an outer cross-sectionaldimension (e.g., diameter) DP, and a distal or second assembly end 109,which may have an outer cross-sectional dimension (e.g., diameter) DD.Assembly 100 may include at least one tube or tube subassembly 110providing a body structure 112 that may extend between ends 101 and 109.Tube subassembly 110 may include at least one tube wall 113 that maydefine at least one internal or intubation passageway 115 extendingwithin and along at least a portion of assembly 100. Wall 113 may alsoinclude at least one proximal or first tube opening 102 that may provideaccess to passageway 115 (e.g., fluid communication between passageway115 and an ambient environment of assembly 100) at or near end 101 ofassembly 100 and at least one distal or second tube opening 108 that mayprovide access to passageway 115 (e.g., fluid communication betweenpassageway 115 and an ambient environment of assembly 100) at or nearend 109 of assembly 100. Moreover, assembly 100 may also include anexpander or expander subassembly 160 that may extend along at least aportion of tube subassembly 110, where expander subassembly 160 mayinclude an external surface 163. As also shown in FIGS. 1-1D, forexample, patient 1 may include a passageway wall 13 that may define apassageway 15 that may extend between at least one proximal or firstaccess opening 11 and a distal or second opening 19. Moreover, patient 1may include a target wall 93 that may define at least a portion of atarget space 95, where a proximal or first target opening 91 of wall 93may be coupled to opening 19 of passageway 15, such that passageway 15may be fluidly coupled to target space 95. As shown in FIGS. 1-1D, forexample, at least a portion of passageway 15 and/or the coupling ofopening 19 and opening 91 may have a cross-sectional dimension (e.g.,diameter) DO, which may be a minimum dimension of patient 1 throughwhich at least a portion of assembly 100 may pass or otherwise existduring any stage of use within patient 1.

When in an insertion state (see, e.g., FIG. 1), assembly 100 may beinserted into patient 1 to a particular position, and then assembly 100may be re-configured into an expanded state (see, e.g., FIG. 1A and/orFIG. 1B and/or FIG. 1C) within patient 1 such that assembly 100 may besafely used within patient 1. After use of assembly 100 in its expandedstate within patient 1, assembly 100 may be re-configured into a removalstate (see, e.g., FIG. 1D) within patient 1 for removal of assembly 100from patient 1. For example, as shown by FIG. 1, assembly 100 may firstbe configured in an insertion state or configuration such that assembly100 may then be at least partially inserted into patient 1. In someembodiments, end 109 of assembly 100 in its insertion state may beinserted into patient 1 in the direction of arrow I through opening 11,through passageway 15, through opening 19, through opening 91, and intotarget space 95, such that at least one opening 108 of assembly 100 maybe within space 95 and/or such that at least one opening 102 of assembly100 may be accessible to an operator O of assembly 100 (e.g., aphysician or nurse or perhaps even patient 1 itself), who may beexternal to at least passageway 15 of patient 1. Assembly 100 may be ofa length LI that may extend between end 101 and end 109 of assembly 100in its insertion state, and where such a length provided by assembly 100in its insertion state may vary based on the size of patient 1 and theprocedure to be performed. As shown in FIG. 1, when assembly 100 is inits insertion state, no portion of expander 160 may have across-sectional dimension (e.g., diameter) greater than dimension DI. Insome embodiments, dimension DD of end 109 and dimension DI of expander160 in the insertion state of assembly 100 may be less than dimension DOof patient 1 such that assembly 100 in its insertion state may be safelyinserted into patient 1 without damaging wall 13 and/or wall 93 ofpatient 1.

After assembly 100 has been inserted into patient 1 while assembly 100is in its insertion state, assembly 100 may be re-configured into anexpanded state within patient 1 such that assembly 100 may thereafter besafely used within patient 1. For example, as shown in each one of FIGS.1A-1C, once assembly 100 in its insertion state has been inserted intoits insertion position of FIG. 1 within patient 1, assembly 100 may bere-configured into an expanded state within patient 1 such that assembly100 may thereafter be safely used in that expanded state within patient1. As shown in each one of FIGS. 1A-1C, when assembly 100 is in itsexpanded state, at least a portion of expander 160 may have a maximumcross-sectional dimension (e.g., diameter) DE that may be at least equalto or greater than dimension DO of patient 1, such that at least aportion of wall 163 of expander 160 may contact or otherwise interactwith at least a portion of wall 93 of target 95 and/or with at least aportion of wall 13 of passageway 15 for safely securing expandedassembly 100 at a particular position within patient 1 and/or for safelypreventing certain material from traveling between wall 163 of expander160 and at least a portion of wall 93 of target 95 and/or at least aportion of wall 13 of passageway 15. One or more of dimensions DE, DI,and DR (e.g., as described below) may be widths defined by expander 160,where such a width may be perpendicular to the length of expander 160(e.g., along the X-axis, which may be perpendicular to the lengthextending between ends 161 and 169 of expander 160 along the Y-axis). Asshown in FIG. 1A, for example, all of expander 160 may be positionedwithin target space 95 when assembly 100 is re-configured from itsinsertion state into its expanded state, such that at least a portion ofwall 163 of expander 160 may contact or otherwise interact with at leasta portion of wall 93 of target 95. Alternatively, as shown in FIG. 1B,for example, all of expander 160 may be positioned within passageway 15when assembly 100 is re-configured from its insertion state into itsexpanded state, such that at least a portion of wall 163 of expander 160may contact or otherwise interact with at least a portion of wall 13 ofpassageway 15. Alternatively, as shown in FIG. 1C, for example, a firstportion of expander 160 may be positioned within passageway 15 and asecond portion of expander 160 may be positioned with target space 95when assembly 100 is re-configured from its insertion state into itsexpanded state, such that at least a first portion of wall 163 ofexpander 160 may contact or otherwise interact with at least a portionof wall 13 of passageway 15 and such that at least a second portion ofwall 163 of expander 160 may contact or otherwise interact with at leasta portion of wall 93 of target 95. As shown in FIGS. 1A-1C, at least aportion of expander 160 may expand at least along the X-axis such that amaximum cross-sectional dimension (e.g., diameter) of expander 160 mayexpand from dimension DI to dimension DE when assembly 100 isreconfigured from its insertion state to its expanded state. As shown inFIGS. 1A-1C, assembly 100 may be of a length LE that may extend betweenend 101 and end 109 of assembly 100 in its expanded state, where such alength LE provided by assembly 100 may vary based on the size of patient1 and may be greater than, less than, or equal to length LI of assembly100 in its insertion state (e.g., the state of FIG. 1) and/or length LRof assembly 100 in its removal state (e.g., the state of FIG. 1D,described below).

Once assembly 100 has been expanded into its expanded state withinpatient 1 (e.g., as shown in any one or more of FIGS. 1A-1C), assembly100 may be safely used within patient 1 in any suitable way, such as inany suitable intubation process. For example, in some embodiments,expanded assembly 100 may be safely used within patient 1 for injectingmaterial (e.g., treatment material, such as nutrients or medicine oroxygen or air) through opening 102, into and through passageway 115,then out of passageway 115 through opening 108, and into target space 95of patient 1, and/or for removing material (e.g., treatment material,such as waste) from target space 95, through opening 108, into andthrough passageway 115, then out of passageway 115 through opening 102away from patient 1. In certain embodiments, target space 95 may be astomach, opening 91 may be a lower esophageal sphincter, passageway 15may be an esophagus, pharynx, throat, and/or nasal cavity, and opening11 may be a nostril or mouth of patient 1, where assembly 100 may beused during a nasogastric intubation process. In other embodiments,target space 95 may be a bladder, opening 91 may be a sphincter,passageway 15 may be a urethra, and opening 11 may be a urinary meatusof patient 1, where assembly 100 may be used during any suitable processthat might otherwise use a Foley catheter. It is to be understood thatassembly 100 may be used with respect to any suitable portions of anysuitable patient 1 for any suitable process, where expander 160 may beexpanded such that at least a portion of wall 163 of expander 160 maycontact or otherwise interact with at least a portion of wall 93 oftarget 95 and/or with at least a portion of wall 13 of passageway 15 forsafely securing expanded assembly 100 at a particular position withinpatient 1 (e.g., for preventing opening 108 and/or end 109 of assembly100 from being inadvertently removed from target space 95 (e.g., in thedirection of arrow R) and/or from being inadvertently inserted too farinto space 95 (e.g., in the direction of arrow I), such as when assembly100 may be used as a Foley catheter) and/or for safely preventingcertain material from traveling between wall 163 of expander 160 and atleast a portion of wall 93 of target 95 and/or between wall 163 ofexpander 160 and at least a portion of wall 13 of passageway 15 (e.g.,for preventing contents of a stomach target 95 from escaping target 95through passageway 15 about the exterior of wall 163 of expander 160(i.e., not through assembly 100), such as towards a trachea or otherportion of patient 1 between expander 160 and end 11 of passageway 15that may cause infections and/or inflammation (e.g., in the direction ofarrow R), such as when assembly 100 may be used as a nasogastric tube).Specifically, reflux of contents from the stomach back into theesophagus has been a persistent problem, especially in the presence ofnasogastric tubes. Contents often attempt to travel back up from thestomach around the tube, thereby causing reflux esophagitis, aspirationpneumonitis, and/or pneumonias.

After assembly 100 has been used in its expanded state within patient 1,assembly 100 may be re-configured into a removal state such thatassembly 100 may thereafter be safely removed from within patient 1(e.g., in the direction of arrow R). For example, as shown in FIG. 1D,once assembly 100 has been used in its expanded state of any of FIGS.1A-1C within patient 1, assembly 100 may be re-configured into a removalstate within patient 1 such that assembly 100 may thereafter be safelyremoved in its removal state from within patient 1. For example, asshown in FIG. 1D, when assembly 100 is in its removal state, no portionof expander 160 may have a cross-sectional dimension (e.g., diameter)greater than dimension DR, where such a dimension DR provided byassembly 100 may vary based on the size of patient 1 and may be greaterthan, less than, or equal to dimension DI of the insertion state. Insome embodiments, dimension DD of end 109 and dimension DR of expander160 in the removal state of assembly 100 may be less than dimension DOof patient 1 such that assembly 100 in its removal state may be safelyremoved from patient 1 without damaging wall 13 and/or wall 93 ofpatient 1. In some embodiments, as shown in FIG. 1D, at least a portionof expander 160 may contract at least along the X-axis such that amaximum cross-sectional dimension (e.g., diameter) of expander 160 maycontract from dimension DE to dimension DR when assembly 100 isreconfigured from its expanded state to its removal state. As shown inFIG. 1D, assembly 100 may be of a length LR that may extend between end101 and end 109 of assembly 100 in its removal state, where such alength LR provided by assembly 100 may vary based on the size of patient1 and may be greater than, less than, or equal to length LI of assembly100 in its insertion state and/or length LE of assembly 100 in itsexpanded state. It is to be noted that, while “proximal” or “proximate”may be used herein to refer to a general direction or end of assembly100 that may be closest to operator O of assembly 100 during use (e.g.,external to patient 1), and while “distal” or “distant” may be usedherein to refer to a general direction or end of assembly 100 that maybe farthest from operator O of assembly 100 during use (e.g., withintarget 95), such directional and orientational terms may be used hereinonly for convenience, and that no fixed or absolute directional ororientational limitations are intended by the use of these words.

In some embodiments, expander subassembly 160 may include a balloon(e.g., a high volume, low pressure balloon) or any other suitableexpander mechanism or component that may be inflatable by air or anyother suitable fluid (e.g., gas or liquid or any other suitablesubstance that may be able to flow into and/or out of the expandermechanism) for enabling the expansion of at least a portion of expandersubassembly 160 (e.g., from dimension DI to dimension DE), which mayallow at least a portion of expander subassembly 160 to contact a wallof patient 1 for securing expanded assembly 100 at a particular positionwithin patient 1 and/or for preventing certain material from travelingbetween expander subassembly 160 and a wall of patient 1.

As shown in FIGS. 2-7, for example, assembly 100 may include tubesubassembly 110 and expander subassembly 160 with such an expandercomponent 164. Tube subassembly 110 may provide a body structure 112that may include tube wall(s) 113 that may provide one or more surfaces111 that may define at least first passageway 115 for extending betweenat least first tube opening 102 that may provide access to passageway115 at or near end 101 of assembly 100 and at least one distal or secondtube opening 108 that may provide access to passageway 115 at or nearend 109 of assembly 100, such that, when assembly 100 is appropriatelypositioned at least partially within patient 1, material may be injectedthrough opening 102, into and through passageway 115, then out ofpassageway 115 through opening 108, and into target space 95 of patient1, and/or such that material may be removed from target space 95,through opening 108, into and through passageway 115, then out ofpassageway 115 through opening 102 away from patient 1. For example, asshown in FIGS. 2-3, passageway 115 may be a single passageway extendingalong a longitudinal axis of tube subassembly 110 (e.g., axis A that mayextend along a Y-axis), although, in other embodiments, passageway 115may be provided by two or more passageways, at least one of which may atleast partially not extend along a longitudinal axis of tube subassembly110. In some embodiments, although not shown, opening 102 may not beprovided at end 101 of assembly 100 but may instead be provided alongand/or through a side surface of tube walks) 113 proximal to end 101,and/or opening 108 may not be provided at end 109 of assembly 100 butmay instead be provided along and/or through a side surface of tubewall(s) 113 proximal to end 109. Tube wall(s) 113 of subassembly 110 mayalso provide one or more exterior surfaces 118 of tube subassembly 110along at least a portion of the length of tube subassembly 110 betweenends 101 and 109.

Expander subassembly 160 may include any suitable expander component 164that may provide exterior surface 163 and interior surface 165 extendingbetween first or proximal expander end 161 and second or distal expanderend 169. Expander component 164 may include at least one proximal orfirst expander opening 162 at or near end 161 and at least one distal orsecond expander opening 168 at or near end 169. As shown, expandersubassembly 160 may be coupled to tube subassembly 110 such that anexpander passageway 167 may be provided between interior surface 165 ofexpander component 164 and along and about exterior surface 118 of tubeassembly 110 between ends 161 and 169 of expander component 164. Forexample, first expander opening 162 may be coupled to and about exteriorsurface 118 of tube assembly 110 at a first position 103 along thelength of tube subassembly 110 using any suitable coupling technique(e.g., adhesive, molding (e.g., blow molding), crimping, etc.) andsecond expander opening 168 may be coupled to and about exterior surface118 of tube assembly 110 at a second position 107 along the length oftube subassembly 110 using any suitable coupling technique (e.g.,adhesive, molding (e.g., blow molding), crimping, etc.) such thatexpander passageway 167 may be provided between interior surface 165 ofexpander component 164 and exterior surface 118 of tube assembly 110 atleast partially along the length of expander component 164 between ends161 and 169. Expander component 164 may be a balloon (e.g., a highvolume, low pressure balloon) or any other suitable expander mechanismor component that may be made of any suitable material (e.g.,polyurethane, silicone, rubber, polyethylene terephthalate (“PET”),nylon, and/or the like) and/or that may be at least semi-compliant andthat may define a space that may be inflatable by air or any othersuitable fluid (e.g., gas or liquid or any other suitable substance thatmay be able to flow into and/or out of the expander mechanism), suchthat the space may change shape when pressure therein may change.

Tube wall(s) 113 of subassembly 110 may also provide one or moresurfaces 117 of tube subassembly 110 that may define at least oneinflation passageway 119 for extending between at least one otherproximal or third tube or inflation opening 104 that may provide accessto passageway 119 (e.g., fluid communication between passageway 119 andan ambient environment of body structure 112 of subassembly 110) at ornear end 101 of assembly 100 and at least one distal or fourth tube orinflation opening 106 that may provide access to passageway 119 (e.g.,fluid communication between passageway 119 and an ambient environment ofbody structure 112 of subassembly 110) at a position along the length ofassembly 100 distal of opening 104 (e.g., between positions 103 and 107along the length of subassembly 110), where opening 106 may be operativeto fluidly couple passageway 119 of tube subassembly 110 to expanderpassageway 167 of expander subassembly 160 (e.g., between positions 103and 107 along the length of subassembly 110). For example, as shown inFIGS. 2-3, passageway 119 may be a single passageway extendingconcentrically about a longitudinal axis of tube subassembly 110 (e.g.,axis A) and/or concentrically about passageway 115, although, in otherembodiments, passageway 119 may be provided by one or two or moredistinct passageways, each of which may extend along and adjacentpassageway 115 but not entirely about passageway 115. In someembodiments, although not shown, at least one opening 104 may not beprovided at end 101 of assembly 100 but may instead be provided alongand/or through a side surface of tube wall(s) 113 proximal to end 101.As shown in FIGS. 2-3, two or more tube openings 106 may be providedthrough tube wall(s) 113 of tube subassembly 110 (e.g., between surfaces117 and 118), each of which may be operative to fluidly couplepassageway 119 of tube subassembly 110 to expander passageway 167 ofexpander subassembly 160 (e.g., a first tube opening 106 may bepositioned proximate end 161 of expander subassembly 160 while a secondtube opening 106 may be positioned proximate end 169 of expandersubassembly 160), while, in other embodiments, only a single tubeopening 106 may be provided for coupling passageways 119 and 167.

Any suitable fluid (e.g., air or a liquid or a combination thereof) maybe injected (e.g., by operator O using any suitable fluid deliverysystem (not shown)) through at least one opening 104, into and throughpassageway 119, then out of passageway 119 through at least one tubeopening 106, and then into expander passageway 167 for at leastpartially inflating expander component 164 about tube subassembly 110for reconfiguring expander subassembly 160 from a natural or relaxed orun-inflated state (e.g., when no external forces of assembly 100 arebeing applied to expander component 164 (e.g., as shown in FIGS. 2 and4)) into an unnatural or tensioned or at least partially inflated state(e.g., when the injected fluid within expander passageway 167 appliesforces to expander component 164 (e.g., as shown in FIGS. 3 and 5-7)),which may reconfigure assembly 100 from an insertion state (e.g., asshown in FIGS. 1 and 2 and 4) into an expanded state (e.g., as shown inFIGS. 1A and 3 and 5-7). Any suitable volume of such injected fluid maybe retained within the combined space defined by fluidly coupledpassageways 119 and 167, for example, by capping opening 104. Passageway119 may be of a fixed volume when body structure 112 may be any suitablerigidity to prevent a collapse of the shape of passageway 119, while thevolume of passageway 167 may change based on the amount of fluidretained within the combined space of fluidly coupled passageways 119and 167. Additionally or alternatively, any suitable fluid (e.g., air orliquid) may be removed (e.g., by operator O using any suitable fluidremoval system (not shown)) from expander passageway 167 through atleast one tube opening 106, into and through passageway 119, then out ofpassageway 119 through at least one opening 104 for at least partiallydeflating expander component 164 about tube subassembly 110 forreconfiguring expander subassembly 160 from an unnatural or tensioned orat least partially inflated state (e.g., when the fluid within expanderpassageway 167 to be removed applies forces to expander component 164(e.g., as shown in FIGS. 3 and 5-7)) into a natural or relaxed orun-inflated state (e.g., when no fluid within expander passageway 167applies force to expander component 164 (e.g., as shown in FIGS. 2 and4)), which may reconfigure assembly 100 from an expanded state (e.g., asshown in FIGS. 1A and 3 and 5-7) into a removal state (e.g., as shown inFIGS. 1D and 2 and 4). Expander subassembly 160 may be coupled to tubesubassembly 110 and configured such that expander subassembly 160 (e.g.,expander component 164) may be expanded to an equilibrium geometry of aparticular unnatural or tensioned or at least partially inflated stateof FIGS. 3 and 5 and 7 when a particular amount (e.g., volume (e.g., avolume of 30 cubic centimeters or 50 cubic centimeters or any othersuitable amount)) of fluid is injected into assembly 100 through opening104 and retained within assembly 100 (e.g., within passageways 119 and167) but when no external force may be applied to expander subassembly160 (e.g., by patient 1 (e.g., by constricting walls 13 of patientpassageway 15)). Such a particular inflated state of expandersubassembly 160 may define a structure of any suitable particularequilibrium geometry. For example, as shown in FIGS. 3 and 5 and 7, theparticular equilibrium geometry of a particular inflated state ofexpander subassembly 160 may include a proximal or first expandercomponent section 166 a, an intermediate or second expander componentsection 166 b, and a distal or third expander component section 166 c,where first expander component section 166 a may extend between position103 and a section 105 along a length ELA of tube subassembly 110 with amaximum cross-sectional dimension (e.g., diameter) EDA, where secondexpander component section 166 b may extend along section 105 along alength ELB of tube subassembly 110 with a maximum cross-sectionaldimension (e.g., diameter) EDB, and where third expander componentsection 166 c may extend between section 105 and position 107 along alength ELC of tube subassembly 110 with a maximum cross-sectionaldimension (e.g., diameter) EDC. Expander subassembly 160 may bemanufactured and/or coupled to tube subassembly 110 and/or inflated inany suitable manner(s) such that the equilibrium geometry of aparticular inflated state of expander subassembly 160 may be operativeto retain the portion of patient 1 at opening 91 of target space 95between first expander component section 166 a and third expandercomponent section 166 c (e.g., along second expander component section166 b) when assembly 100 is in its expanded state and appropriatelypositioned within patient 1 (see, e.g., FIG. 5). In some embodiments,ELA may be about 3-7 centimeters and/or ELC may be about 2-4 centimetersand/or ELB may be about 0.5-5 centimeters. Expander component section166 a may include a tooth-shape and/or a cylindrical shape or discshaped or any other suitable shape along length ELA (e.g., whenexpanded), and/or expander component section 166 c may be spherical ordisc shaped or any other suitable shape along length ELC (e.g., whenexpanded) to minimize its volume, where EDC may be about 5-7 centimeterswhile ELC may be about 2-4 centimeters in the equilibrium expanded stateof expander assembly 160. In some embodiments, as shown, the geometry ofa particular inflated state of one, some, or each expander componentsection of expander subassembly 160 may be symmetrical or asymmetricalabout longitudinal axis A of tube subassembly 110. For example, amaximum cross-sectional dimension (e.g., diameter) EDA1 of firstexpander component section 166 a between a first (e.g., top) side oftube subassembly 110 and expander component 164 may be the same as ordifferent than a maximum cross-sectional dimension (e.g., diameter) EDA2of first expander component section 166 a between a second (e.g.,bottom) side of tube subassembly 110 and expander component 164 (e.g.,opposite sides with respect to longitudinal axis A), and/or a maximumcross-sectional dimension (e.g., diameter) EDB1 of second expandercomponent section 166 b between a first (e.g., top) side of tubesubassembly 110 and expander component 164 may be the same as ordifferent than a maximum cross-sectional dimension (e.g., diameter) EDB2of second expander component section 166 b between a second (e.g.,bottom) side of tube subassembly 110 and expander component 164 (e.g.,opposite sides with respect to longitudinal axis A), and/or a maximumcross-sectional dimension (e.g., diameter) EDC1 of third expandercomponent section 166 c between a first (e.g., top) side of tubesubassembly 110 and expander component 164 may be the same as ordifferent than a maximum cross-sectional dimension (e.g., diameter) EDC2of third expander component section 166 c between a second (e.g.,bottom) side of tube subassembly 110 and expander component 164 (e.g.,opposite sides with respect to longitudinal axis A). In someembodiments, second expander component section 166 b may be preventedfrom expanding beyond a particular cross-sectional dimension of itsequilibrium geometry due to the structural composition of expandercomponent 164 (e.g., despite at least a portion of first expandercomponent section 166 a and/or at least a portion of third expandercomponent section 166 c being able to expand beyond a particularcross-sectional dimension of its equilibrium geometry (see, e.g., anincrease in a dimension of third expander component section 166 cbetween its equilibrium geometry of FIG. 5 and a varied geometry of FIG.6)). Alternatively, any suitable mechanism 159, such as a rigid band ofmaterial, may be positioned about expander component 164 along at leasta portion of second expander component section 166 b to prevent secondexpander component section 166 b from expanding beyond maximumcross-sectional dimension (e.g., diameter) EDB of the equilibriumgeometry of FIGS. 3 and 5 while still allowing a portion of expanderpassageway 167 to extend through second expander component section 166 bbetween expander component 164 and surface 118 of tube subassembly 110,where EDB may be about 0.5-1.5 centimeters in the equilibrium expandedstate of expander assembly 160. First expander component section 166 amay have any suitable pressure (e.g., no greater than 40 mmHg for aparticular size patient) when in the equilibrium expanded state ofexpander assembly 160, such as a pressure operative to retain assembly160 in a desired functional position within patient 1 while alsoenabling walls 13 of passageway 15 to naturally contract and expand(e.g., to enable patient 1 to safely breath). Therefore, first expandercomponent section 166 a and third expander component section 166 c maydefine distinct portions of expander passageway 167, even when fluidlycoupled via a portion of expander passageway 167 defined by secondexpander component section 166 b.

When assembly 100 is in an insertion state (see, e.g., FIGS. 1, 2, and4, where expander subassembly 160 may be in a natural or relaxed orun-inflated state such that maximum cross-sectional dimension (e.g.,diameter) DI of expander subassembly 160 (e.g., cross-sectionaldimension (e.g., diameter) of at least third expander component section166 c) may be less than cross-sectional dimension (e.g., diameter) DO ofopening 91 and/or of passageway 15 of patient 1), assembly 100 may beinserted (e.g., in the direction of arrow I) into patient 1 to aparticular position (e.g., a position at which at least a portion ofthird expander component section 166 c may be positioned within targetspace 95 of patient 1 and a position at which at least a portion offirst expander component section 166 a may be positioned withinpassageway 15 of patient 1 and/or a position at which at least a portionof second expander component section 166 b may be positioned within orproximate opening 91 of patient 1), as shown in FIG. 4. Then, assembly100 may be re-configured into an expanded state (see, e.g., FIGS. 1A, 3,and 5, where expander subassembly 160 may be in a particular unnaturalor tensioned or at least partially inflated state such that maximumcross-sectional dimension (e.g., diameter) DE of expander subassembly160 (e.g., at least dimension EDC of third expander component section166 c) may be greater than cross-sectional dimension (e.g., diameter) DOof opening 91 of patient 1) within patient 1, as shown in FIG. 5 (e.g.,when a particular amount (e.g., volume) of fluid is injected (e.g., byoperator O in the direction of arrows FI of FIGS. 3 and 5) into assembly100 through opening 104 and retained within assembly 100 (e.g., withinpassageways 119 and 167) but when no external force may be applied toexpander subassembly 160 (e.g., by patient 1 (e.g., by constrictingwalls of patient passageway 15 on first expander component section 166a)). In such a particular unnatural or tensioned or at least partiallyinflated state of FIGS. 1A, 3, and 5, the volume of fluid withinexpander subassembly 160 may be set such that the pressure of firstexpander component section 166 a may be less than 40 mmHg (e.g., basedon the volume of fluid injected into subassembly 160 and the differencein volumes between first expander component section 166 a and thirdexpander component section 166 c) or any other suitable volume that maybe operative to at least partially secure assembly 100 in the functionalposition of FIGS. 1A, 3, and 5 within patient 1 (e.g., such thatdimension EDA of first expander component section 166 a may be largerthan dimension DO of opening 19/91 to resist insertion of first expandercomponent section 166 a into target space 95 and/or such that dimensionEDA of first expander component section 166 a may contact or otherwiseinteract with at least a portion of wall 13 of passageway 15 for safelysecuring expanded assembly 100 at a particular position within patient 1and/or for safely preventing certain material from traveling betweenwall 163 of first expander component section 166 a and at least aportion of wall 13 of passageway 15) but that may also be operative notto prevent or resist contraction of passageway 15 (e.g., contraction ofcross-sectional dimension DW of passageway 15 of FIGS. 5-7 (e.g., due topatient 1 swallowing)). Therefore, the particular unnatural or tensionedor at least partially inflated state of FIGS. 1A, 3, and 5 of firstexpander component section 166 a may be configured (e.g., based on thegeometry of first expander component section 166 a and the volume offluid within first expander component section 166 a in such a state(e.g., within the portion of passageway 167 defined by first expandercomponent section 166 a in such a state)) to provide a pressure that mayachieve these goals of assembly positioning and assembly functionalityand patient safety (e.g., a pressure of no more than 40 mmHG, such thatpressure of 40 mmHG or greater by walls of the patient may be operativeto deform first expander component section 166 a). The bigger the ratioof the volume of first expander component section 166 a to the volume ofthird expander component section 166 c is, the more pressure there maybe for first expander component section 166 a (e.g., if the volume ofthird expander component section 166 c is much larger than the volume offirst expander component section 166 a, the pressure of first expandercomponent section 166 a may be lower). As shown in FIGS. 3 and 5, whenassembly 100 is in its expanded state, at least a portion of expandersubassembly 160 may have a cross-sectional dimension (e.g., at least aportion of third expander component section 166 c may have across-sectional dimension) that may be at least equal to or greater thandimension DO of opening 19/91 of patient 1, such that at least a portionof surface 163 of expander component 164 of expander subassembly 160 maycontact or otherwise interact with at least a portion of wall 93 oftarget 95 for safely securing at least a portion of expanded assembly100 at a particular position within patient 1 (e.g., for securing atleast a portion of third expander component section 166 c within target95 and/or for resisting and/or preventing that portion from passing inthe direction of arrow R through opening 91 and into passageway 15)and/or for safely preventing certain material from traveling betweensurface 163 of expander component 164 and at least a portion of wall 93of target 95 and/or at least a portion of wall 13 of passageway 15(e.g., such that movement of any material between target space 95 andpassageway 15 about the exterior of assembly 100 in its expanded statemay be limited or prevented). Additionally or alternatively, as shown inFIGS. 3 and 5, when assembly 100 is in its expanded state, at least aportion of expander subassembly 160 may have a cross-sectional dimension(e.g., at least a portion of first expander component section 166 a mayhave a cross-sectional dimension) that may be at least equal to orgreater than dimension DO of opening 19/91 of patient 1, such that atleast a portion of surface 163 of expander component 164 of expandersubassembly 160 may contact or otherwise interact with at least aportion of wall 13 of passageway 15 for safely securing at least aportion of expanded assembly 100 at a particular position within patient1 (e.g., for securing at least a portion of first expander componentsection 166 a within passageway 95 and/or for resisting and/orpreventing that portion from passing in the direction of arrow I throughopening 19 and into target space 95) and/or for safely preventingcertain material from traveling between surface 163 of expandercomponent 164 and at least a portion of wall 93 of target 95 and/or atleast a portion of wall 13 of passageway 15 (e.g., such that movement ofany material between target space 95 and passageway 15 about theexterior of assembly 100 in its expanded state may be limited orprevented). In some embodiments, the maximum cross-sectional dimension(e.g., diameter) EDC of third expander component section 166 c may belarger than maximum cross-sectional dimension (e.g., diameter) EDA offirst expander component section 166 a in a particular inflated state(e.g., the state of FIGS. 3 and 5) and/or the maximum cross-sectionaldimension of each one of third expander component section 166 c andfirst component section 166 a may be larger than the maximumcross-sectional dimension EDB of second expander component section 166 b(e.g., to match the sizes of target space 95, opening 19/91, andpassageway 15 within which respective expander components 166 c, 166 b,and 166 a may be positioned in the functional position of expandedassembly 100 of FIG. 5). When in the functional position of FIG. 5,material may be passed through expanded subassembly 100 (e.g., throughpassageway 115 of tube subassembly 110) between target space 95 andpassageway 15, either in the direction of arrow I or in the direction ofarrow R.

Although the amount (e.g., volume) of fluid that may be injected intoand then held within expander passageway 167 of assembly 100 whenassembly 100 is in the particular expanded state of FIGS. 3 and 5 may befixed or predetermined, a dimension of at least a portion of patient 1may vary during use of assembly 100 in that state. For example,cross-sectional dimension DW of passageway 15 may expand and/or contractwhile assembly 100 is positioned within patient 1, such as due topatient 1 swallowing and/or due to involuntary contractions of wall 13.Assembly 100 may be configured to alter its geometry in conjunction withsuch variation of patient 1 so that assembly 100 may maintain itsability to maintain the position of assembly 100 within patient 1 (e.g.,to maintain at least a portion of expander component 160 within targetspace 95 (e.g., at least a portion of third expander component section166 c distal to opening 19/91) and to maintain at least a portion ofexpander component 160 within passageway 15 (e.g., at least a portion offirst expander component section 166 a proximal to opening 19/91)). Forexample, as shown between FIGS. 5 and 6, expander subassembly 160 may beconfigured such that, in a particular inflated state (e.g., of FIGS. 3and 5-7 (e.g., with a fixed particular amount of fluid within passageway167)), when walls of patient 1 may contract or squeeze against expandersubassembly 160 or otherwise reduce the cross-sectional dimension DW orany other suitable cross-sectional dimension of passageway 15 (e.g., inthe direction of arrows CI of FIG. 6), first expander component section166 a may be operative to at least partially or fully deflate by passingfluid from within a portion of passageway 167 of first expandercomponent section 166 a to within a portion of passageway 167 of thirdexpander component section 166 c (e.g., in the direction of arrows FD ofFIG. 6 (e.g., via a portion of passageway 167 of second expandercomponent section 166 b and/or via passageway 119 and two or moredifferent openings 106)), thereby further inflating third expandercomponent section 166 c (e.g., increasing its inflated volume, which mayincrease its cross-sectional dimension EDC and/or its length ELC).Therefore, while expander subassembly 160 may be configured to have anequilibrium geometry of FIGS. 3 and 5 when a particular amount of fluidis held within expander passageway 167 for a particular expanded stateof assembly 100 (e.g., when no external forces are applied to assembly100 (e.g., by patient 1)), expander subassembly 160 may also beconfigured to adjust its geometry (e.g., from the equilibrium geometryof FIG. 5 to an adjusted geometry of FIG. 6) when the amount of fluidheld within expander passageway 167 remains the same but when anexternal force is applied to assembly 100 (e.g., by contraction forcesin the direction of arrows CI by patient 1) as the external force maydeform expander 160 so as to force fluid from one portion of passageway167 to another portion of passageway 167 (e.g., by forcing fluid to passfrom within a portion of passageway 167 of first expander componentsection 166 a to within a portion of passageway 167 of third expandercomponent section 166 c (e.g., in the direction of arrows FD of FIG.6)). Such an adjustment of the geometry of a particular expanded stateof assembly 100 between that of FIG. 5 and that of FIG. 6 may maintain arelationship between assembly 100 and patient 1 for maintaining assembly100 at the functional position within patient 1 (e.g., maintain a largercross-sectional dimension of third expander component section 166 cwithin target space 95 than that of opening 19/91 to prevent end 109 ofassembly 100 from being inadvertently removed from target space 95and/or maintain a larger cross-sectional dimension of first expandercomponent section 166 a within passageway 15 than that of opening 19/91to prevent end 109 of assembly 100 from being inadvertently insertedfurther into target space 95 and potentially harming walls 93). Suchcompressibility of first expander component section 166 a may beoperative to avoid damage of wall 13 from high pressures (e.g., if wall13 were to contract and pressure in first expander component section 166a were to rise without compressing (e.g., without fluid being able toleave first expander component section 166 a), such a non-compressiblefirst expander component section 166 a might explode (e.g., pop) orcompress vessels in wall 13, thereby reducing blood supply). Therefore,in some embodiments, a particular equilibrium geometry of a particularinflated state of expander subassembly 160 (e.g., of FIG. 5) may beconfigured such that some or even all (e.g., at least 25%, at least 50%,at least 75%, or 100%) of the volume of fluid within first expandercomponent section 166 a in that equilibrium geometry (e.g., within theportion of passageway 167 defined by first expander component section166 a in that equilibrium geometry) may be transferred to and heldwithin third expander component section 166 c (e.g., within the portionof passageway 167 defined by third expander component section 166 c)when in a deformed geometry of that particular inflated state (e.g., ofFIG. 6) without popping or otherwise rupturing third expander componentsection 166 c or any other portion of expander subassembly 160 (e.g.,the volume of fluid within third expander component section 166 c in theequilibrium geometry (e.g., within the portion of passageway 167 definedby third expander component section 166 c in the equilibrium geometry)combined with some, most, or all of the volume of fluid within firstexpander component section 166 a in the equilibrium geometry (e.g.,within the portion of passageway 167 defined by first expander componentsection 166 a in the equilibrium geometry) may together be held withinthird expander component section 166 c (e.g., within the portion ofpassageway 167 defined by third expander component section 166 c) in thedeformed geometry without damaging expander subassembly 160). Therefore,third expander component section 166 c may not be frilly expanded in itsequilibrium geometry but may instead be configured to expand further(e.g., to be filled with more fluid to expand to a greater deformedgeometry), while first expander component section 166 a may or may notbe fully expanded in its equilibrium geometry (e.g., first expandercomponent section 166 a may not be able to take on much more fluid thanthe amount within first expander component section 166 a in itsequilibrium geometry (e.g., within the portion of passageway 167 definedby first expander component section 166 a in its equilibrium geometry)).The material of expander component 164 (e.g., as semi-compliant orcompliant) may be operative to enable expansion of third expandercomponent section 166 c by accommodating more volume (e.g., to preventrising pressure in first expander component section 166 a (e.g., due tocompression of first expander component section 166 a that may lead toexpulsion of air from first expander component section 166 a into thirdexpander component section 166 c)). First expander component section 166a may be configured to expand to its inflated state with no more than aparticular maximum pressure (e.g., a pressure of no more than 40 mmHG,such that pressure of 40 mmHG or greater by walls of the patient (e.g.,during contraction of passageway 15 by walls 13 while the patientbreathes) may be operative to deform first expander component section166 a).

Additionally or alternatively, as shown between FIGS. 6 and 7, expandersubassembly 160 may be configured such that, in a particular inflatedstate (e.g., of FIGS. 3 and 5-7 (e.g., with a fixed particular amount offluid within passageway 167)), when walls of patient 1 may expand awayfrom expander subassembly 160 or otherwise increase the cross-sectionaldimension DW or any other suitable cross-sectional dimension ofpassageway 15 (e.g., in the direction of arrows CR of FIG. 7), firstexpander component section 166 a may be operative to at least partiallyinflate (e.g., re-inflate) by receiving fluid from within a portion ofpassageway 167 of third expander component section 166 c to within aportion of passageway 167 of first expander component section 166 a(e.g., in the direction of arrows FR of FIG. 7 (e.g., via a portion ofpassageway 167 of second expander component section 166 b and/or viapassageway 119 and two or more different openings 106)), therebyre-inflating first expander component section 166 a and increasing itscross-sectional dimension EDA back to that of the equilibrium ofassembly 100 of FIGS. 3 and 5. Therefore, while expander subassembly 160may be configured to have an equilibrium geometry of FIGS. 3 and 5 and 7when a particular amount of fluid is held within expander passageway 167for a particular expanded state of assembly 100 (e.g., when no externalforces are applied to assembly 100 (e.g., by patient 1)), expandersubassembly 160 may also be configured to adjust its geometry (e.g.,from the adjusted geometry of FIG. 6 back to an equilibrium geometry ofFIG. 7) when the amount of fluid held within expander passageway 167remains the same but when an external force is removed from (e.g.,terminated from being applied to) assembly 100 (e.g., when expansionforces in the direction of arrows CR by patient 1 remove or terminatethe application of a force on first expander component section 166 a bypatient 1) and may force fluid from one portion of passageway 167 toanother portion of passageway 167 (e.g., by forcing fluid to pass fromwithin a portion of passageway 167 of third expander component section166 c to within a portion of passageway 167 of first expander componentsection 166 a (e.g., in the direction of arrows FR of FIG. 7)). Such anadjustment of the geometry of a particular expanded state of assembly100 between that of FIG. 6 and that of FIG. 7 may maintain arelationship between assembly 100 and patient 1 for maintaining assembly100 at the functional position within patient 1 (e.g., maintain a largercross-sectional dimension of third expander component section 166 cwithin target space 95 than that of opening 19/91 to prevent end 109 ofassembly 100 from being inadvertently removed from target space 95)and/or to prevent patient wall injury (e.g., esophageal wall injury).Such expansion and contraction of dimension DW of patient 1 may be dueto peristalsis of the esophagus or any other suitable portion of patient1 that may routinely occur during any suitable procedure using assembly100. By configuring at least a portion of expander subassembly 160 todeflect or contract or compress or deflate inwardly and reboundoutwardly in tandem with expansion and contraction forces of opposingwalls of patient 1 about expander subassembly 160, expander subassembly160 may be enabled to safely interact with patient 1 during use ofassembly 100. In some embodiments, the volume of first expandercomponent section 166 a may be the same as or less than the volume ofthird expander component section 166 c when assembly 100 is in itsequilibrium geometry of a particular expanded state (e.g., of FIGS. 3,5, and 7). In some particular embodiments, assembly 100 may beconfigured such that the volume of first expander component section 166a may be less than the volume of third expander component section 166 cwhen assembly 100 is in its equilibrium geometry of a particularexpanded state. Additionally or alternatively, assembly 100 may beconfigured such that the entirety of, or substantially the entirety of,or at least half of, or less than half of but at least some of thevolume of fluid within the portion of expander passageway 167 of firstexpander component section 166 a when assembly 100 is in its equilibriumgeometry of a particular expanded state may be transferred to within theportion of expander passageway 167 of third expander component section166 c or any other portion of assembly 100 when the equilibrium geometryof the particular expanded state is deformed to a deformed geometry ofthe particular expanded state (e.g., the deformed geometry of FIG. 6(e.g., when an external force is applied to expander component 164(e.g., by patient 1))) without expander subassembly 160 being damaged(e.g., popping or rupturing or deforming such that it cannot return toits equilibrium geometry when external forces are removed). Therefore,at least some or all of the fluid within the portion of expanderpassageway 167 of first expander component section 166 a when assembly100 is in its equilibrium geometry of a particular expanded state maysafely be combined with all of the fluid within the portion of expanderpassageway 167 of third expander component section 166 c when assembly100 is in its equilibrium geometry of the particular expanded state andheld within the portion of expander passageway 167 of third expandercomponent section 166 c when assembly 100 is in a deformed geometry ofthe particular expanded state. In some embodiments, expander subassembly160 may be inflated to its equilibrium expanded state of FIG. 5 yet witheach one of component sections 166 a, 166 b, and 166 c positioned atleast partially within target space 95 and then assembly 100 may bepulled in the direction of arrow R such that expander subassembly 160may be positioned with respect to patient 1 as shown in FIG. 5 (e.g.,such movement of assembly 100 from an equilibrium expanded state ofsubassembly 160 within target space 95 to an equilibrium expanded stateof subassembly 160 with first component section 166 a outside of targetspace 95 but in passageway 15 may involve expander subassembly 160deforming to a deformed expanded state while first component section 166a passes through opening 91 (e.g., similar to the deformation betweenFIGS. 5, 6, and 7)). Therefore, subassembly 160 may be provided with atleast two expandable reservoirs that may be operative to communicatefluid therebetween, such that a first reservoir may receive fluid fromand then expel fluid back into a second reservoir such that thecommunicated fluid may enable the second reservoir to contract andexpand (e.g., breath) in concert with walls of a patient that may be incontact with the second reservoir.

As mentioned, second expander component section 166 b of assembly 100 ofFIGS. 2-7 may be prevented from expanding at all or at least beyond aparticular dimension of its equilibrium geometry due to the structuralcomposition of expander component 164 and/or due to any suitablelimiting mechanism 159 of assembly 100. Alternatively, as shown in FIGS.8 and 9, an expander subassembly 160′ of an assembly 100′, which mayotherwise be similar to assembly 100 of FIGS. 2-7, may include anysuitable limiting mechanism 159′ (e.g., adhesive, molding (e.g., blowmolding), crimping, etc.) that may physically couple (e.g., seal) aportion of expander component 164 (e.g., at least a portion or theentirety of second expander component section 166 b) to a portion ofsection 105 along tube subassembly 110, which may split expanderpassageway 167 into at least two distinct expander sub-passageways 167 aand 167 b that may be fluidly coupled via two or more openings 106 andpassageway 119 but not via another sub-passageway of passageway 167(e.g., not through limiting mechanism 159′). Alternatively, one or moreelements of limiting mechanism 159′ may be operative to secure ends oftwo distinct expander components 164 to a portion of section 105 alongtube subassembly 110 (e.g., passageway 167 a may be defined by a firstexpander component and passageway 167 b may be defined by a secondexpander component that may be distinct from the first expandercomponent (e.g., two distinct balloons may be coupled to and about andalong different portions of tube subassembly 110)). This may enable thedimension(s) of second expander component section 166 b to remain thesame or substantially the same as the dimension(s) of section 105 alongtube subassembly 110 (e.g., to allow for opening 19/91 to be in itsnatural state without undue interference from an expandable secondexpander component section 166 b). Similarly, expander component 164 ofassembly 100 may be provided by two or more distinct expander components164 (e.g., first expander component section 166 a may be distinct fromthird expander component section 166 c).

In some embodiments, as shown, for example, in FIGS. 2-3, assembly 100may also include a supplemental tube passageway 195 that may be definedby at least a portion of one or more walls 113 of tube subassembly 110that may be provided to treat (e.g., extract material from and/or injectmaterial into) a supplemental region of patient 1 that may be proximalto target 95 and proximal to expander subassembly 160 when assembly 100is in its expanded state in a functional position within patient 1(e.g., the position of FIGS. 5-7). For example, as shown, supplementaltube passageway 195 may extend from a proximal end 191 to at least onedistal end 199. A proximal opening 192 for passageway 195 may beprovided at or near proximal end 191 and a distal opening 198 forpassageway 195 may be provided at or near distal end 199. Fluid may beinjected into patient 1 (e.g., by operator O) through passageway 195from opening 192 to opening 198 and/or fluid may be removed from patient1 (e.g., by operator O) through passageway 195 from opening 198 toopening 192. As shown, at least a portion of passageway 195 may beprovided adjacent to passageway 119 and/or passageway 115. As shown inFIGS. 10-12 (without expander passageway 119 (only for simplifying FIGS.10-12)), an external surface 196 of a wall defining at least a portionof supplemental tube passageway 195 may protrude out from a portion ofsurface 118 to expose opening 198 at end 199 in a direction facing thedirection of expander subassembly 160 (e.g., in direction of arrow I ofFIG. 3 for insertion of assembly 100 into a patient), where such aconfiguration of surface 196 may prevent direct contact between opening198 and a wall 13 of patient 1 (e.g., to prevent direct suction on awall of patient tissue) but instead surface 196 may contact patient 1 incertain situations of use while enabling an opening for fluidcommunication between supplemental tube passageway 195 and passageway 15of patient 1 (e.g., in a direction along the axis of assembly 100).Alternatively, as shown in FIGS. 13-15 (without expander passageway 119(only for simplifying FIGS. 13-15)), an external surface 196′ of a walldefining at least a portion of a supplemental tube passageway 195′ mayprotrude out from a portion of surface 118 to expose a first opening 198a at end 199 in a direction facing the direction of expander subassembly160 (e.g., in direction of arrow I for insertion of assembly 100 into apatient, similar to opening 198 of FIGS. 10-12) as well as a secondopening 198 b at end 199 in a direction substantially opposite of firstopening 198 a (e.g., in direction of arrow R for removal of assembly 100into a patient), where such a configuration of surface 196′ may preventdirect contact between each opening 198 and a wall 13 of patient 1(e.g., to prevent direct suction on a wall of patient tissue) butinstead surface 196 may contact patient 1 in certain situations of usewhile enabling multiple openings for fluid communication betweensupplemental tube passageway 195′ and passageway 15 of patient 1 (e.g.,up and down along the axis of assembly 100).

Various materials may be used for various elements of an assembly 100,which may vary based on the procedure and/or patient in which assembly100 is to be used. As just one example, when assembly 100 may be usedfor a nasogastric intubation procedure, tube subassembly 110 may be madeof polyurethane, silicone, polyvinyl chloride, or rubber, expandersubassembly 160 may be a molded piece and/or extruded piece and/or maybe made of silicone, polyurethane, rubber, thermoplastic elastomers, orthe like and/or may be coupled to tube subassembly 110 via any suitabletype of mechanism or crimp or bond or adhesive (e.g., cyanoacrylate orsilicone glue). One or more of any or all portions of expandersubassembly 160 and tube subassembly 110, and/or the like of assembly100 may be provided with an alkaline coating on one or both of itsinterior and exterior walls, such that when material (e.g., food oracidic stomach contents) travels through such components, the acidity ofthe material may get neutralized. Additionally or alternatively, one ormore of any or all portions of expander subassembly 160 and tubesubassembly 110, and/or the like of assembly 100 may be at leastpartially X-ray visible such that an operator may ensure that it isproperly placed within patient 1 for a particular procedure.

Assembly 100 may be used to treat a patient in any suitable manner. Insome embodiments, while expander subassembly 160 may be in a natural orrelaxed or un-inflated state (e.g., while the geometry of expander 164may be similar to the geometry of surface 118 of structure 112), distalend 109 of assembly 100 may be initially inserted into patient 1 and fedthrough passageway 15, through openings 19/91, and into target space 95.The length of assembly 100 necessary to enable distal end 109 to bepositioned within space 95 while proximal end 101 may be accessible toan operator may vary based on the size of patient 1. When a particularlength (e.g., 65 centimeters) of assembly 100 has been inserted (e.g.,in the direction of arrow I) for a given patient such that an operatormay believe distal end 109 is within or close to space 95, or at anyother suitable moment, the operator may attempt to determine thelocation of expander 164 with respect to space 95. In some embodiments,an initial volume of fluid may be injected into passageway 167 viapassageway 119 for expanding a portion of passageway 167 to betterdifferentiate the geometry of at least a portion of expander 164 fromthe geometry of structure 112, and then any suitable technique may beused to detect the location of expander 164 within patient 1. Forexample, one or more of any or all portions of expander subassembly 160or tube subassembly 110 may be at least partially X-ray visible (e.g.,using a Barium marker dye on a portion of expander 164) such that anoperator may ensure that it is properly placed within patient 1 for aparticular procedure. This technique may be used even when expandersubassembly 160 may be in a natural or relaxed or un-inflated state. Theoperator may detect the location of expander 164 and further insertassembly 100 into patient 100 until expander 164 is at least partiallypositioned within space 95. In some embodiments, the operator mayposition the entirety of expander 164 within space 95. Once expander isat least partially positioned within space 95, a volume of fluid may beinjected into passageway 167 via passageway 119 for expanding at least aportion of passageway 167. In some embodiments, an amount of fluid maybe injected into and retained within passageways 119 and 167 forexpanding a portion of passageway 167 defined by first expandercomponent section 166 a and for expanding a portion of passageway 167defined by third expander component section 166 c (e.g., to the state ofFIG. 3). In some embodiments, this inflation may occur while each one ofexpander component sections 166 a-166 c are within space 95. Then, whilethe injected fluid is maintained within passageways 119 and 167,assembly 100 may be retracted in the direction of arrow R for pulling atleast first expander component section 166 a through openings 19/91 andinto passageway 15 (e.g., to the position of FIG. 5). This process ofpulling inflated first expander component section 166 a through openings19/91 may cause fluid to be temporarily removed from first expandercomponent section 166 a and into another portion of passageway 167, suchas into expander component section 166 c (e.g., as similarly describedabove with respect to FIG. 6), such that the geometry of expandercomponent section 166 a may be squashed or deformed when pulled throughopenings 19/91. Then, when passed through openings 19/91 and positionedwithin passageway 15, that fluid may return to first expander componentsection 166 a (e.g., as similarly described above with respect to FIG.7). Completion of retraction of expander component section 166 a throughopenings 19/91 may be felt by the operator. This retraction of a portionof inflated expander 164 through openings 19/91 in the direction ofarrow R may ensure that proximal expander component section 166 a anddistal expander component section 166 c are properly positioned onopposite sides of openings 19/91 (e.g., respectively, in passageway 15and space 95). Any attempt to further retract assembly 100 may be met byresistance from inflated expander component section 166 c against wall93 of space 95 about opening 91 (e.g., indicating that distal expandercomponent section 116 c within space 95 is abutting the gastroesophageal junction).

FIG. 16 is a flowchart of an illustrative process 1600 for intubating apatient with an intubation assembly, wherein the intubation assemblyincludes a body structure, an intubation passageway extending within thebody structure and along at least an intubation portion of the length ofthe body structure from a proximal intubation passageway opening to adistal intubation passageway opening, an expander subassembly coupled tothe body structure for defining an expander passageway between theexpander subassembly and the body structure, and an inflation passagewayextending along at least an inflation portion of the length of the bodystructure from a proximal inflation passageway opening to a distalinflation passageway opening, wherein the distal inflation passagewayopening fluidly couples the inflation passageway to the expanderpassageway, wherein the expander subassembly includes a proximalexpander subassembly portion defining a proximal portion of the expanderpassageway between the proximal expander subassembly portion and aproximal portion of the body structure and a distal expander subassemblyportion defining a distal portion of the expander passageway between thedistal expander subassembly portion and a distal portion of the bodystructure, wherein the distal inflation passageway opening fluidlycouples the inflation passageway to the distal portion of the expanderpassageway, wherein the inflation passageway further includes anintermediate inflation passageway opening that fluidly couples theinflation passageway to the proximal portion of the expander passageway,and wherein the proximal portion of the expander passageway is fluidlycoupled to the distal portion of the expander passageway only via theinflation passageway. At operation 1602 of process 1600, the expandersubassembly may be positioned within the patient. For example, asdescribed above and shown in FIG. 1, an assembly 100, which may includeexpander 160 coupled to tube subassembly 110 of FIGS. 2-9, may bepositioned within patient 1. At operation 1604 of process 1600, whilethe expander subassembly is positioned within the patient, a volume offluid may be provided within the combined space defined by the inflationpassageway and the expander passageway, wherein the providing expandseach one of the proximal portion of the expander passageway and thedistal portion of the expander passageway, and at operation 1606 ofprocess 1600, the volume of the fluid may be retained within thecombined space. For example, as described with respect to FIGS. 1A, 3,and 5, fluid may be injected into and retained within passageway 167 viapassageway 119 for expanding a portion of passageway 167 defined byfirst expander component section 166 a and for expanding a portion ofpassageway 167 defined by third expander component section 166 c. Atoperation 1608 of process 1600, while the volume of the fluid isretained within the combined space, other fluid may be passed throughthe intubation passageway for treating the patient. For example, asdescribed with respect to FIGS. 1A-1C, fluid may be passed throughpassageway 115 for treating patient 1.

It is understood that the operations shown in process 1600 of FIG. 16are merely illustrative and that existing operations may be modified oromitted, additional operations may be added, and the order of certainoperations may be altered.

While there have been described expandable assemblies and methods forusing and making the same, it is to be understood that many changes maybe made therein without departing from the spirit and scope of thesubject matter described herein in any way. Insubstantial changes fromthe claimed subject matter as viewed by a person with ordinary skill inthe art, now known or later devised, are expressly contemplated as beingequivalently within the scope of the claims. Therefore, obvioussubstitutions now or later known to one with ordinary skill in the artare defined to be within the scope of the defined elements. It is alsoto be understood that various directional and orientational terms suchas “proximal” and “distal,” “up” and “down,” “front” and “back,” “top”and “bottom” and “side,” “length” and “width” and “thickness” and“diameter” and “cross-section” and “longitudinal,” “X-” and “Y-” and“Z-,” and the like that may be used herein only for convenience, andthat no fixed or absolute directional or orientational limitations areintended by the use of these words. For example, the assemblies andpatients can have any desired orientations. If reoriented, differentdirectional or orientational terms may need to be used in theirdescription, but that will not alter their fundamental nature as withinthe scope and spirit of the subject matter described herein in any way.

Therefore, those skilled in the art will appreciate that the inventioncan be practiced by other than the described embodiments, which arepresented for purposes of illustration rather than of limitation.

1.-16. (canceled)
 17. A method of intubating a patient with anintubation assembly comprising a body structure, an intubationpassageway extending within the body structure and along at least anintubation portion of the length of the body structure from a proximalintubation passageway opening to a distal intubation passageway opening,an expander subassembly coupled to the body structure for defining anexpander passageway between the expander subassembly and the bodystructure, and an inflation passageway extending along at least aninflation portion of the length of the body structure from a proximalinflation passageway opening to a distal inflation passageway opening,wherein the distal inflation passageway opening fluidly couples theinflation passageway to the expander passageway, wherein the expandersubassembly comprises a proximal expander subassembly portion defining aproximal portion of the expander passageway between the proximalexpander subassembly portion and a proximal portion of the bodystructure and a distal expander subassembly portion defining a distalportion of the expander passageway between the distal expandersubassembly portion and a distal portion of the body structure, whereinthe distal inflation passageway opening fluidly couples the inflationpassageway to the distal portion of the expander passageway, wherein theinflation passageway further comprises an intermediate inflationpassageway opening that fluidly couples the inflation passageway to theproximal portion of the expander passageway, and wherein the proximalportion of the expander passageway is fluidly coupled to the distalportion of the expander passageway only via the inflation passageway,the method comprising: positioning the expander subassembly within thepatient; and while the expander subassembly is positioned within thepatient: providing a volume of fluid within the combined space definedby the inflation passageway and the expander passageway, wherein theproviding expands each one of the proximal portion of the expanderpassageway and the distal portion of the expander passageway; retainingthe volume of the fluid within the combined space; and while the volumeof the fluid is retained within the combined space, passing other fluidthrough the intubation passageway for treating the patient. 18.(canceled)
 19. An intubation assembly comprising: a body structureextending from a proximal body end to a distal body end; an intubationpassageway extending within the body structure and along at least anintubation portion of the length of the body structure from a proximalintubation passageway opening to a distal intubation passageway opening;an expander subassembly coupled to the body structure for defining anexpander passageway between the expander subassembly and the bodystructure; and an inflation passageway extending along at least aninflation portion of the length of the body structure from a proximalinflation passageway opening to a distal inflation passageway opening;an auxiliary passageway extending along at least an auxiliary portion ofthe length of the body structure from a proximal auxiliary passagewayopening to a distal auxiliary passageway opening, wherein: the distalauxiliary passageway opening is directed along the length of the bodystructure at least one of towards the expander subassembly or away fromthe expander subassembly; the distal inflation passageway openingfluidly couples the inflation passageway to the expander passageway; andwhen a volume of fluid is retained within the combined space defined bythe inflation passageway and the expander passageway, the expandersubassembly is operative to remain in an expanded configuration.
 20. Theintubation assembly of claim 19, wherein the distal auxiliary passagewayopening is not directed away from the body structure.
 21. An intubationassembly comprising: a body structure extending from a proximal body endto a distal body end; an intubation passageway extending within the bodystructure and along at least an intubation portion of the length of thebody structure from a proximal intubation passageway opening to a distalintubation passageway opening; an expander subassembly coupled to thebody structure for defining an expander passageway between the expandersubassembly and the body structure; and an inflation passagewayextending along at least an inflation portion of the length of the bodystructure from a proximal inflation passageway opening to a distalinflation passageway opening, wherein: the distal inflation passagewayopening fluidly couples the inflation passageway to the expanderpassageway; the expander subassembly comprises: a proximal expandersubassembly portion defining a proximal portion of the expanderpassageway between the proximal expander subassembly portion and aproximal portion of the body structure; and a distal expandersubassembly portion defining a distal portion of the expander passagewaybetween the distal expander subassembly portion and a distal portion ofthe body structure; the proximal portion of the expander passageway isfluidly coupled to the distal portion of the expander passageway; andwhen a volume of fluid is retained within the combined space defined bythe inflation passageway and the expander passageway: an amount of thevolume of the fluid is transferred from one of the proximal portion ofthe expander passageway or the distal portion of the expander passagewayto the other one of the proximal portion of the expander passageway orthe distal portion of the expander passageway when an external force isapplied to one of the proximal expander subassembly portion or thedistal expander subassembly portion; and the amount of the volume of thefluid is transferred from the other one of the proximal portion of theexpander passageway or the distal portion of the expander passageway tothe one of the proximal portion of the expander passageway or the distalportion of the expander passageway when the external force is removedfrom the one of the proximal expander subassembly portion or the distalexpander subassembly portion.
 22. The intubation assembly of claim 21,wherein the expander subassembly further comprises an intermediateexpander subassembly portion defining an intermediate portion of theexpander passageway between the intermediate expander subassemblyportion and an intermediate portion of the body structure.
 23. Theintubation assembly of claim 22, wherein the intermediate portion of theexpander passageway fluidly couples the proximal portion of the expanderpassageway to the distal portion of the expander passageway.
 24. Theintubation assembly of claim 23, wherein the inflation passageway alsofluidly couples the proximal portion of the expander passageway to thedistal portion of the expander passageway.
 25. The intubation assemblyof claim 23, wherein the inflation passageway does not fluidly couplethe proximal portion of the expander passageway to the distal portion ofthe expander passageway.
 26. The intubation assembly of claim 22,wherein the proximal expander subassembly portion, the intermediateexpander subassembly portion, and the distal expander subassemblyportion are all provided by a single expander component.
 27. Theintubation assembly of claim 26, wherein the expander componentcomprises a balloon.
 28. The intubation assembly of claim 22, wherein,when the volume of the fluid is retained within the combined spacedefined by the inflation passageway and the expander passageway, another amount of the volume of the fluid is maintained within theintermediate portion of the expander passageway when the external forceis applied to the one of the proximal expander subassembly portion orthe distal expander subassembly portion.
 29. The intubation assembly ofclaim 28, wherein, when the volume of the fluid is retained within thecombined space defined by the inflation passageway and the expanderpassageway, the other amount of the volume of the fluid is maintainedwithin the intermediate portion of the expander passageway when theexternal force is not applied to the one of the proximal expandersubassembly portion or the distal expander subassembly portion.
 30. Theintubation assembly of claim 22, further comprising a mechanismpositioned about at least a portion of the intermediate expandersubassembly portion and operative to prevent the intermediate expandersubassembly portion from expanding beyond a certain amount.
 31. Theintubation assembly of claim 21, wherein: the distal inflationpassageway opening fluidly couples the inflation passageway to thedistal portion of the expander passageway; and the inflation passagewayfurther comprises an intermediate inflation passageway opening thatfluidly couples the inflation passageway to the proximal portion of theexpander passageway.
 32. The intubation assembly of claim 31, whereinthe proximal portion of the expander passageway is fluidly coupled tothe distal portion of the expander passageway only via the inflationpassageway.
 33. The intubation assembly of claim 31, wherein: theproximal expander subassembly portion comprises a proximal expandercomponent extending between a first proximal expander component endcoupled about the body structure at a first position along the length ofthe body structure and a second proximal expander component end coupledabout the body structure at a second position along the length of thebody structure; the proximal expander component defines the proximalportion of the expander passageway between the proximal expandercomponent and the proximal portion of the body structure; the distalexpander subassembly portion comprises a distal expander componentextending between a first distal expander component end coupled aboutthe body structure at a third position along the length of the bodystructure and a second distal expander component end coupled about thebody structure at a fourth position along the length of the bodystructure; and the distal expander component defines the distal portionof the expander passageway between the distal expander component and thedistal portion of the body structure.
 34. The intubation assembly ofclaim 33, wherein: the proximal expander component comprises a firstballoon; and the distal expander component comprises a second balloonthat is different than the first balloon.
 35. The intubation assembly ofclaim 34, wherein the proximal portion of the expander passageway isfluidly coupled to the distal portion of the expander passageway onlyvia the inflation passageway.
 36. The intubation assembly of claim 21,wherein at least a portion of the inflation passageway extends withinthe body structure.
 37. The method of claim 17, further comprising:while the volume of the fluid is retained within the combined space:transferring an amount of the volume of the fluid from one of theproximal portion of the expander passageway or the distal portion of theexpander passageway to the other one of the proximal portion of theexpander passageway or the distal portion of the expander passagewaywhen an external force is applied to one of the proximal expandersubassembly portion or the distal expander subassembly portion; andtransferring the amount of the volume of the fluid from the other one ofthe proximal portion of the expander passageway or the distal portion ofthe expander passageway to the one of the proximal portion of theexpander passageway or the distal portion of the expander passagewaywhen the external force is removed from the one of the proximal expandersubassembly portion or the distal expander subassembly portion.